ADASUVE Inhalation powder (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
ADASUVE 9.1 mg inhalation powder, pre-dispensed.
Qualitative and quantitative composition
Each single-dose inhaler contains 10 mg loxapine and delivers 9.1 mg loxapine.
Pharmaceutical form
Inhalation powder, pre-dispensed (inhalation powder). White device with a mouthpiece on one end and a pull-tab protruding from the other end.
Therapeutic indications
ADASUVE is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of ...
Posology and method of administration
ADASUVE should <b>only</b> be administered in a hospital-setting under the supervision of a healthcare professional. <b>Short-acting beta-agonist bronchodilator treatment should be available for treatment ...
Contraindications
Hypersensitivity to the active substance, or to amoxapine. Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive ...
Special warnings and precautions for use
Correct use of ADASUVE inhaler is important for administration of the full dose of loxapine. Healthcare professionals should ensure the patient will use the inhaler properly. ADASUVE may have limited effectiveness ...
Interaction with other medicinal products and other forms of interaction
Concomitant administration of benzodiazepines or other hypnosedatives or respiratory depressants may be associated with excessive sedation and respiratory depression or respiratory failure. If benzodiazepine ...
Fertility, pregnancy and lactation
Pregnancy New-born infants exposed repeatedly to antipsychotics during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary ...
Effects on ability to drive and use machines
ADASUVE has major influence on the ability to drive and use machines. Because of the potential for sedation/somnolence, fatigue, or dizziness, patients should not operate hazardous machines, including ...
Undesirable effects
Summary of the safety profile Assessment of adverse reactions from clinical study data is based on two Phase 3 and one Phase 2A short-term (24-hour) placebo-controlled clinical trials enrolling 524 adult ...
Overdose
No cases of overdosage of ADASUVE were reported in clinical studies. Symptoms In the event of accidental overdosage, signs and symptoms will depend on the number of units taken and individual patient tolerance. ...
Pharmacodynamic properties
Pharmacotherapeutic group: psycholeptics, antipsychotics ATC code: N05AH01 The efficacy of loxapine is proposed to be mediated through high affinity antagonism of dopamine D<sub>2</sub> receptors and serotonin ...
Pharmacokinetic properties
Absorption Administration of ADASUVE resulted in rapid absorption of loxapine with a median time of maximum plasma concentration (T<sub>max</sub>) by 2 minutes. Loxapine exposure in the first 2 hours after ...
Preclinical safety data
Non-clinical safety data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, and genotoxicity, except for changes to reproductive tissues related ...
List of excipients
None.
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
Store in the original pouch until ready for use in order to protect from light and moisture. This medicinal product does not require any special temperature storage conditions.
Nature and contents of container
The white inhaler (housing) is molded from a medical-grade polycarbonate. Each inhaler is provided in a sealed, multilaminate aluminum foil pouch. ADASUVE 9.1 mg is supplied in a carton of 1 or 5 units. ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Ferrer Internacional, S.A., Gran Vía Carlos III, 94, 08028- Barcelona, España
Marketing authorization number(s)
EU/1/13/823/002 (5 single-dose inhalers) EU/1/13/823/004 (1 single-dose inhaler)
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 February 2013
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